SUREFIRE SCORPION NEEDLE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS REPETITIVE ACTUATIONS, WHICH CAN LEAD TO BENDING OF THE NEEDLE TIP. ADDITIONALLY, THE REPORTED FAILURE APPEARS TO BE MORE CONSISTENT WITH AN ISSUE RELATED TO THE SCORPION SUTURE PASSER. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE EVALUATION OF THE CUSTOMER-PROVIDED IMAGE.

Description of Event or Problem

ON 09-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13991N SUREFIRE SCORPION NEEDLE TIP WAS BENT. IT WAS REPORTED THAT THE SCORPION FAILED TO PASS THE SUTURE, SEVERAL ATTEMPTS WERE MADE, THEN THE SCORPION NEEDLE WAS CHECKED, AND IT WAS FOUND THAT THE TIP WHERE THE NOTCH IS LOCATED WAS BENT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.